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Clinical Trials in Australia / NCT06447168
Active, not recruiting Observational

A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment

NCT06447168 · tracked via the Priya Life Science Australia tracker
Sponsor
Ipsen
Phase
Observational
Started
2024-10-14
Last updated
2026-10-01

Condition(s) studied

Primary Biliary Cholangitis

Study summary

This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting.

PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged.

The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms including pruritus (itching) and fatigue. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done.

In this study the main aim is to observe the effectiveness, safety and tolerability of elafibranor in participants with PBC who are receiving treatment in real world setting. The total study duration for each participants will be 60 months (approximately 5 years).

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participant has provided written informed consent and agrees to comply with the study protocol. * Participant with PBC diagnosis. * Participant for whom the treating physician has decided to start or participants who are currently receiving treatment with commercialized elafibranor. * If a participant has a caregiver who agrees to complete the caregiver questionnaires, an informed consent should be collected from the caregiver before any data is collected. Exclusion Criteria: * Participant is currently participating or, plans to participate in an investigational drug study or medical device study containing active substance. * Participant with known hypersensitivity to the product or to any of its excipients. * Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.

Primary outcome measure(s)

  • Percentage of participants with response to treatment — At month 6
    Defined as alkaline phosphatase (ALP) \<1.67 x upper limit of normal (ULN) and total bilirubin (TB) ≤ULN and ALP decrease ≥15% from baseline.

Trial sites (72)

FacilityCityRegionStatus
Southern California Research Center Coronado California
Cedars-Sinai Medical Center Los Angeles California
University of California Davis Medical Center Sacramento California
South Denver Gastroenterology,P.C. Englewood Colorado
Yale University School of Medicine New Haven Connecticut
Schiff Center for Liver Diseases - University of Miami Miami Florida
Beth Israel Deaconess Medical Center, Liver Research Center Boston Massachusetts
Virtua Center for Liver Disease - Cherry Hill Cherry Hill New Jersey
Northwell Health Inc, Center for Liver Disease and Transplantation Manhasset New York
UNC Hospitals, The University of North Carolina at Chapel Hill Chapel Hill North Carolina
Cleveland Clinic Foundation Cleveland Ohio
Medical University of South Carolina (MUSC) Charleston South Carolina
Liver Center of Texas Dallas Texas
Baylor College of Medicine - Advanced Liver Therapies Houston Texas
Texas Digestive Specialists McAllen Texas
Intermountain Medical Center Murray Utah
Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond Richmond Virginia
Virginia Commonwealth University Medical Center - West Hospital Richmond Virginia
Velocity Clinical Research Seattle Washington
Royal Prince Alfred Hospital Camperdown Australia
St Vincent's Hospital Fitzroy Australia
Medizinische Universitaetsklinik Graz Graz Austria
Medical University Innsbruck Innsbruck Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern Linz Austria
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM) Montreal Quebec
University of Calgary Calgary Canada
London Health Sciences Centre (LHSC) - University Hospital London Canada
The Ottawa Hospital - General Campus Ottawa Canada
(G.I.R.I) GI Research Institute Foundation Vancouver Canada
Charite Universitatsmedizin Berlin Berlin Germany
DRK Kliniken Berlin Mitte Berlin Germany
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt Germany
Studiengesellschaft BSF Halle Germany
Gastroenterologsiche Studiengesellschaft Herne Herne Germany
Universitaet des Saarlandes Homburg Germany
Universitaetsklinikum Leipzig Leipzig Germany
General Hospital of Athens Laiko Athens Greece
University Hospital of Heraklion Heraklion Greece
University General Hospital of Larissa Larissa Greece
University General Hospital of Patras Pátrai Greece

+ 32 more sites — see the full list on the official registry below.

More Ipsen trials in Australia

A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis Recruiting
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis Recruiting
A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults Active, not recruiting

Other trials for the same condition

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06447168 on ClinicalTrials.gov ↗ ← All trials in Australia